DelinquencyNCT02112201
The ProGirls Study
A study testing Integrated intervention for parents and adolescent girls in people with Delinquency and HIV Risk, run by Oregon Research Institute at 1 site in United States.
Trial summary
Girls in the juvenile justice system who have high rates of delinquency, drug abuse, and trauma are particularly at risk for engaging in risky sexual behavior and for contracting HIV/AIDS or other sexually transmitted infections (STIs). Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delinquency, HIV Risk, Substance Use
- What is being tested?
- Integrated intervention for parents and adolescent girls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- female, age 13-18 years
- living in Lane County, Oregon
- living at home (biological/adoptive, foster, or other relative care)
- at least one criminal referral and on probation or a formal accountability contract with the juvenile justice system
- documented drug use from juvenile justice risk assessment
- traumatic exposure
- no imminent plans to be placed in out-of-home care
Who cannot join
- meet criteria for posttraumatic stress disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing HIV/STI Risk Behavior in Girls With Delinquency, Drug Abuse, & Trauma
Girls in the juvenile justice system who have high rates of delinquency, drug abuse, and trauma are particularly at risk for engaging in risky sexual behavior and for contracting HIV/AIDS or other sexually transmitted infections (STIs). No effective prevention programs for girls who have this combination of behaviors is known to exist at this time. Researchers are developing, assessing, and implementing a family-centered prevention program to decrease girls' participation in the risky behaviors associated with the spread of HIV and STIs. The program also includes a group-based training and support program for parents.
Read the detailed description
This study aims to test an intervention to reduce HIV/STI risk behavior among girls in the juvenile justice system with the triple-threat risk of delinquency, drug abuse, and trauma. This is a competing continuation of the ProTeens study (Preventing Drug Abuse \& HIV/AIDS in Delinquent Youths: An Integrated Intervention) which focused on testing a family-centered intervention for treating HIV risk, drug use, and delinquency in boys. The current study will adapt the ProTeens intervention for girls. Girls and their parent(s) will be randomly assigned to either a family-centered intervention condition (INT; n = 100) or to an active comparison condition (n = 100) consisting of group therapy and case management (GCM). The INT condition will consist of individually administered HIV preventive intervention for adolescent girls involved in the juvenile justice system that integrally addresses delinquency, drug abuse, and trauma exposure, along with group-based training and support for parents. The girl and parent components will run concurrently for three months. The GCM condition will consist of group therapy and case management for girls provided as usual by the juvenile justice department. We will examine intervention effects on proximal outcomes measured at 12 months, the effects of childhood adversity on proximal outcomes, and the mediation of intervention effects. Longer term outcomes will be measured at 24 months. Data will be collected through in-person interviews and questionnaires from focal participants and their parents, official arrest records, and urinary analysis.
- Conditions
- Delinquency, HIV Risk, Substance Use, Trauma Exposure
- Being tested
- Integrated intervention for parents and adolescent girls
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated intervention for parents and adolescent girlsBehavioural
The intervention will consist of individually administered preventive curriculum for adolescent girls involved in the juvenile justice system that integrally addresses delinquency, drug abuse, and trauma exposure, along with group-based training and support for parents.
| Study group | Role | What they receive |
|---|---|---|
| Integrated intervention for parents and adolescent girls | Experimental | Twelve session parent education and support group; twelve session one-on-one adolescent skills training intervention Receives: Behavioral: Integrated intervention for parents and adolescent girls |
| Treatment as usual | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in HIV/STIs risk behavior in delinquent girls
Girls in the intervention condition are expected to have significantly lower rates of HIV/STI risk behaviors compared to girls in the control condition at each of the time-points post-baseline. Data will be collected through in-person interviews and questionnaires from focal participants and their parents.
Measured: Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Secondary outcomes (1)
Reduction in criminal offending
Girls in the intervention condition are expected to have significantly lower rates of criminal offending behavior compared to girls in the control condition at each of the time points post-baseline. Data will be collected through in-person interviews and questionnaires from focal participants and their parents and official arrest records.
Measured: Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2018
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DelinquencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana K Smith, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112201
- Sponsor's protocol ID
- DA025857
- Status last verified
- Sep 2020
- First submitted
- 3 Apr 2014
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing HIV/STI Risk Behavior in Girls With Delinquency, Drug Abuse, & Trauma
- ClinicalTrials.gov ID
- NCT02112201
- Acronym / sponsor ID
- DA025857
- Conditions
- Delinquency, HIV Risk, Substance Use, Trauma Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2018 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Girls in the juvenile justice system who have high rates of delinquency, drug abuse, and trauma are particularly at risk for engaging in risky sexual behavior and for contracting HIV/AIDS or other sexually transmitted infections (STIs). No effective prevention programs for girls who have this combination of behaviors is known to exist at this time. Researchers are developing, assessing, and implementing a family-centered prevention program to decrease girls' participation in the risky behaviors associated with the spread of HIV and STIs. The program also includes a group-based training and support program for parents.
Detailed description
This study aims to test an intervention to reduce HIV/STI risk behavior among girls in the juvenile justice system with the triple-threat risk of delinquency, drug abuse, and trauma. This is a competing continuation of the ProTeens study (Preventing Drug Abuse \& HIV/AIDS in Delinquent Youths: An Integrated Intervention) which focused on testing a family-centered intervention for treating HIV risk, drug use, and delinquency in boys. The current study will adapt the ProTeens intervention for girls. Girls and their parent(s) will be randomly assigned to either a family-centered intervention condition (INT; n = 100) or to an active comparison condition (n = 100) consisting of group therapy and case management (GCM). The INT condition will consist of individually administered HIV preventive intervention for adolescent girls involved in the juvenile justice system that integrally addresses delinquency, drug abuse, and trauma exposure, along with group-based training and support for parents. The girl and parent components will run concurrently for three months. The GCM condition will consist of group therapy and case management for girls provided as usual by the juvenile justice department. We will examine intervention effects on proximal outcomes measured at 12 months, the effects of childhood adversity on proximal outcomes, and the mediation of intervention effects. Longer term outcomes will be measured at 24 months. Data will be collected through in-person interviews and questionnaires from focal participants and their parents, official arrest records, and urinary analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated intervention for parents and adolescent girls | Experimental | Behavioral: Integrated intervention for parents and adolescent girlsTwelve session parent education and support group; twelve session one-on-one adolescent skills training intervention |
| Treatment as usual | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- female, age 13-18 years
- living in Lane County, Oregon
- living at home (biological/adoptive, foster, or other relative care)
- at least one criminal referral and on probation or a formal accountability contract with the juvenile justice system
- documented drug use from juvenile justice risk assessment
Key exclusion criteria (1 listed)
- meet criteria for posttraumatic stress disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated intervention for parents and adolescent girlsThe intervention will consist of individually administered preventive curriculum for adolescent girls involved in the juvenile justice system that integrally addresses delinquency, drug abuse, and trauma exposure, along with group-based training and support for parents. | Behavioural | Integrated intervention for parents and adolescent girls |
Primary outcome
Reduction in HIV/STIs risk behavior in delinquent girls
Time frame: Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Girls in the intervention condition are expected to have significantly lower rates of HIV/STI risk behaviors compared to girls in the control condition at each of the time-points post-baseline. Data will be collected through in-person interviews and questionnaires from focal participants and their parents.
1 secondary outcome
Reduction in criminal offending
Time frame: Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana K Smith, PhD principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated intervention for parents and adolescent girls in people with Delinquency and HIV Risk, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in HIV/STIs risk behavior in delinquent girls (time frame: Baseline and post intervention (6 mos); 12 & 24 month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020; AzTrials last refreshed its copy on 27 Oct 2026.